A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFangYi
About this trial
This study, called PERSEVERE, examines how local treatment for early breast cancer affects people's health and daily lives over time.
People who join the study will have early-stage breast cancer and receive treatment such as surgery and other therapies that are used before or after surgery. The study does not include people with late-stage (metastatic) breast cancer.
Researchers want to learn about short- and long-term side effects that can happen during or after treatment. These may include tiredness, trouble sleeping, emotional distress, pain, or changes in heart or lung function. The study also looks at how these effects impact participants' quality of life.
Participants will be asked to complete surveys about how they feel. They will also have health checks, such as heart tests, lung function tests, and blood samples. Tissue samples from surgery will also be collected.
The goal is to understand better how different people respond to breast cancer treatment and find ways to support long-term recovery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18 years or older
Diagnosed with stage I, II, or III invasive breast cancer confirmed by pathology or cytology
No signs of metastatic disease (cancer that has spread to other parts of the body)
Willing and able to complete health questionnaires and attend follow-up visits
Disqualifiers
Have metastatic breast cancer or local recurrence
Have already received curative treatment (surgery, chemo, etc.) for the current breast cancer before joining the study
Are currently pregnant or breastfeeding
Have a history of another cancer within the past 5 years (except for non-melanoma skin cancer or in-situ cervical cancer)
Trial population
Participants will be recruited from multiple hospitals across China. The study is coordinated by the Cancer Hospital, Chinese Academy of Medical Sciences (CAMS), and includes collaborating sites such as Shanxi Cancer Hospital and the CAMS Cancer Hospital Shenzhen branch. Additional centers from both northern and southern regions of China will be added as the study expands. The study population includes women diagnosed with stage I-III breast cancer who are receiving local therapy in real-world clinical settings across diverse geographic areas.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sampling
Procedure/SurgeryAt baseline, participants will undergo peripheral blood collection using EDTA tubes. A total of 10 mL of venous blood will be collected and processed into plasma and peripheral blood mononuclear cells (PBMCs). Plasma samples will be stored at -80°C, and PBMCs will be cryopreserved in liquid nitrogen. These samples will be used for future biomarker discovery, multi-omics analysis, and studies of biological mechanisms underlying treatment-related toxicities.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Early-Stage Breast Cancer Patients Receiving Local Therapy1 intervention
Trial outcomes
Primary outcomes
1
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Quality of life will be measured using the EORTC QLQ-C30, a 30-item questionnaire that includes a global health status/QoL scale, five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, nausea/vomiting, pain), and several single-item symptom measures. Score range: Each scale is transformed to a 0-100 scale. Interpretation: For functional and global health status scales, higher scores indicate better functioning or quality of life. For symptom scales, higher scores indicate worse symptom burden. Changes from baseline will be analyzed across follow-up timepoints.
Time frame
Baseline, 1week, 1 month, 3 months, 6 months, 12 months, annually up to 5 yearsSecondary outcomes
1
Trajectories and Risk Factors for Cancer-Related Fatigue Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue Module (EORTC QLQ-FA12)
Cancer-related fatigue will be assessed using the EORTC QLQ-FA12, a 12-item validated module measuring fatigue in three dimensions: physical, emotional, and cognitive. Score range: Each dimension is linearly transformed to a score from 0 to 100. Interpretation: Higher scores indicate greater fatigue (worse outcome). This outcome will track changes in fatigue over time and examine associations with clinical, biological, and psychosocial factors.
Time frame
Baseline, 1 week, 1 month, 3 months, 6 months, 12 months, then annually up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FangYi
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov